Trifecta Clinical’s Rick Ward and Dr. Richard Mohs from the Global Alzheimer’s Platform Foundation (GAP) recently came together via webinar to discuss how to speed the delivery of innovative therapies to those afflicted with Alzheimer’s by reducing the time and cost of clinical trials. The webinar, Positively Disrupting Rater Training Certification in Alzheimer’s Research, can be found online. Trifecta’s InvestigatorSpace® platform, a fully integrated training and communication study portal, is being leveraged by GAP for this initiative to support the reduction and elimination of redundant training in Alzheimer’s disease studies.
The need for a reformed clinical trial process in Alzheimer’s studies comes from the various inefficiencies in current trials. The greatest inefficiency is the redundant training that raters must go through in order to administer a study. Highly qualified raters often have to spend time retraining on the same scales for multiple studies because in the current system, raters are required to be recertified at the beginning of every study. Although sponsors must ensure the quality of the data collected, rater recertification is a frustrating burden, as raters are often recertified 4-5 times on roughly the same scales. This is a very time-consuming process that slows study start-up and takes the rater’s valuable time and focus away from ongoing studies. Additionally, most sponsors expect that sites will already have prequalified, pre-trained raters, and some have had difficulty identifying new qualified raters because no natural path to receive that training and qualify new raters currently exists.
Addressing Inefficiencies: A 3-Step Process
In order to tackle these current inefficiencies, GAP is working on introducing a 3-step process that will reduce the redundancy and frustration of re-training and increase training efficiency and speed. The first step is to establish a “minimum standard” that defines rater certification across multiple scales. By standardizing scales across all studies, some of the time-consuming frustration in retaking training is eliminated. The next step is to establish a database to collect information on the experience and quality of ratings previously performed by site raters in monitored studies. This database, which is where InvestigatorSpace comes in, will be a repository for that information and will make it easier for sponsors to identify qualified raters.
The third step in this process involves simplifying the rater certification process itself. Proven raters (those who have a medical background, prior experience and previous certification) will be certified through a ‘grandfathering’ exercise. Their level of mastery will be determined by video proof reviewed by an expert rater. Experienced raters (raters with greater than one year experience working with any cognitively impaired population) will go through targeted scale training, and new raters (those who have limited or no previous experience working with a specific scale) will undergo extensive training.
To move forward with research and find new cures and treatments to help patients and families suffering from Alzheimer’s, the rater training process must become more sustainable and allow pathways for new and experienced raters alike. This collaboration is an effort to introduce a vision and plan that maintains the quality of the data produced from trial sites while increasing efficiency. Database management including documentation of proven raters is certainly key to ensuring a program like this is successful, and going forward, the quality of the program will be monitored and performance data will be collected. Standardizing scales and reforming the time-consuming process of redundant rater recertification combined with the creation of new training paths for both experienced and new raters will reduce training redundancy and help increase efficiency and speed in Alzheimer’s disease trials.
To learn more about how Trifecta is partnering to reduce the frustration and inefficiency of redundant rater training across a wide variety of therapeutic areas including Alzheimer’s, Oncology, Dermatology, CNS and Autoimmune diseases, please contact firstname.lastname@example.org